27 September 2021 - Eisai and EA Pharma announced today the additional approval for a high dose regimen in adult patients with ulcerative colitis and for a new regimen in paediatric patients regarding fully human anti-TNF alfa monoclonal antibody Humira (adalimumab).

This approval allows for 40 mg weekly treatment or 80 mg biweekly treatment in addition to conventional 40 mg biweekly treatment as a remission maintenance therapy, which is expected to maintain remission in many patients. 

Furthermore, by having been added as a treatment option for ulcerative colitis in paediatric patients, it is expected that as the first at-home/self-injectable drug in Japan for paediatric patients with ulcerative colitis, Humira will improve convenience for paediatric patients and their guardians in addition to reducing burdens due to hospital visits.

Read Eisai press release